Alnylam Pharmaceuticals, Inc. (ALNY) Overstated the Efficacy of its Onpattro Lipid Complex Injection

According to the complaint against Alnylam's officers and directors for alleged violations of the Securities Exchange Act of 1934 between February 15, 2018 and September 12, 2018, in August 2018, Alnylam Pharmaceuticals, Inc. (ALNY) issued press releases announcing the approval of Onpattro (patisiran) for the treatment of hereditary ATTR amyloidosis in adults in both the U.S. and Europe. On September 12, 2018, Nomura/Instinet analyst Christopher Marai reported that a review document released by the FDA's Center for Drug Evaluation and Research "highlights greater risk" with respect to certain trials of Alnylam's patisiran lipid complex injection, and notes "concerns over cardiac deaths in patients treated with ONPATTRO" suggesting a "limited market opportunity in TTRcardiomyopathy, and a potential platform safety risk." Marai asserted that "some comments on the lack of cardiac efficacy call into question claims made by in this regard." On this news, Alnylam's stock fell $5.60 per share to close at $94.75 on September 12, 2018.

Then, on September 27, 2018, Alnylam announced an issue with another drug – givosiran – which reported 22% of its patients suffered serious side effects compared to 10% of patients on placebo. Alnylam's stock fell even further on this news, and continues to trade below its pre-disclosure price.

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